曲美他嗪治疗慢性充血性心力衰竭疗效的系统评价

Effect of Trimetazidine for Congestive Heart Failure: A Systematic Review

目的系统评价曲美他嗪治疗慢性充血性心力衰竭的疗效及其安全性。方法运用Cochrane系统评价方法,检索Cochrane图书馆临床对照试验资料库(2006年第3期)、MEDLINE(1990～2006)、EMbase(1990～2004)和中国生物医学文献光盘数据库(1990-2006),筛选曲美他嗪治疗充血性心力衰竭的RCTs和交叉设计试验,并应用RevMan 4．2软件进行统计分析。结果共检索到相关文献101篇,评价后纳入4个RcTs和2个交叉试验。Meta分析结果显示,与常规治疗比较,曲美他嗪+常规抗心衰治疗能降低NYHA分级[RR 0．85,95％CI(0．76,0．95)]、增加最大运动时间[WMD 51．40 s,95％CI(15．56,87．25)]、增加最大代谢当量[WMD 0．82单位, 95％CI(0．28,1．37)]、增加左室射血分数[WMD 7.31％,95％CI(6．05, 8．57)]、减少左室舒张末期内径[WMD-5．36 mm,95％CI(-6．42,-4．31)]、减少左室舒张末期容量[WMD-12．16 ml,95％CI(-15．26,-9．06)]、减少左室收缩末期内径[WMD-5．48 mm,95％CI(-6．05,-4．91)]、减少左室收缩末期容量[WMD-16．94 ml,95％CI(-20．34,-13．55)]、降低血清脑纳素水平[WMD-239．59 pg／ml,95% CI(-276．53,-202．65)]及提高生活质量指数[WMD 12．36,95％CI(5．16,19．55)]。结论曲美他嗪+常规抗心衰治疗在降低患者心衰级别,改善心功能系列指标,提高生活质量等方面均优于常规治疗。但由于本次系统评价纳入的病例数仅262例,且多集中于缺血性心脏疾病的心衰,加之部分研究的质量不足,测量指标多为中间指标。因此有必要继续开展高质量、大样本量、以死亡为终点指标以及非缺血性心衰为亚组分析的随机对照试验,以获得更可靠的证据。

Objective To evaluate the efficacy and safety of trimctazidinc （TMZ） for chronic congestive heart failure. Methods We searched The Cochranc Library （Issue 3, 2006）, MEDLINE （1990-2006）, EMBASE （1990-2004）, and the Chinese Biomedicine Database （1990- 2006 ） for parallel group randomized controlled trials （RCTs） and cross-over design trials comparing TMZ and placebo or open controls for patients with heart failure.We used The Cochranc Collaboration＇s RcvMan 4.2 software for data analyses. Results Four RCTs and two cross-over design trials were included. Mcta-analyscs showed that： compared with the control group, TMZ may improve the NYHA cardiac functional grade （RR 0.85, 95%CI 0.76 to 0.95）, increase the total exercise time （WMD 51.40 seconds, 95%CI 15.56 to 87.25）, the maximal metabolic equivalents （WMD 0.82, 95%CI 0.28 to 1.37）, and the ejection fraction （WMD 7.29%, 95%CI 6.28 to 8.31）, but may decrease the left vcntricular enddiastolic volume （WMD -12.19 ml, 95%CI -15.29 to -9.09）, the left ventricular end-diastolic diameter （WMD -6.05 mm, 95%CI -7.10 to -4.99）, the left ventricular end-systolic volume （WMD -16.94 ml, 95%CI -20.34 to -13.55）, the left ventricular endsystolic diameter （WMD -5.42 mm, 95%CI -5.98 to -4.86）, and the serum brain natfiuretic peptide （WMD -239.59 pg/ml, 95%CI -276.53 to -202.65）. TMZ may also improve the quality of life （WMD 12.36, 95%CI 5.16 to 19.55）. Conclusions TMZ plus standard medical therapy has a beneficial effect on the indices of cardiac function, and may also improve the patient＇s quality of life. However, because available RCTs for this systematic review are too small and poor quality, （mainly focusing on the heart failure induced by ischemic heart diseases and merely taking intermediate indices as outcome measures）, further highquality large-scale RCTs with death as the endpoint and which include subgroup analysis of non-ischemic heart failure, are required in order to provide more reliable evidence.